FDA.report

Owl Night Guard

Primary DI
00860014754609
Brand
Owl Night Guard
Company
OWL DENTAL LAB INC
Model
1
Device description
Owl Hybrid Night Guard
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MQCMouthguard, Prescription

Product Code Classifications

CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions

SubmissionSupplement
K253641000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K253641000Owl Night GuardOwl Dental Lab, Inc.2026-02-26OBR

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860014754609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014754609008600147546098600147546090860014754609

GMDN Terms

TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
125242583
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00860014754616Owl Night Guard12026-03-05
00860014754623Owl Night Guard12026-03-05
00860014754630Owl Impression Kit12026-03-05

Other Devices Sharing Product Codes

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